危重症极早产儿早期补充维生素 D 的安全性和疗效：一项随机试验的辅助研究。

Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial.

机构信息

Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama.

Department of Pediatrics, Yale University, New Haven, Connecticut.

出版信息

J Acad Nutr Diet. 2023 Jan;123(1):87-94. doi: 10.1016/j.jand.2022.06.012. Epub 2022 Jun 18.

DOI:10.1016/j.jand.2022.06.012

PMID:35728797

Abstract

BACKGROUND

Despite substantial evidence that vitamin D deficiency is highly prevalent among infants born extremely preterm (≤28 weeks' of gestation), several consensus statements do not recommend vitamin D doses >400 IU/day for these infants. Safety remains a concern.

OBJECTIVE

The study aim was to determine safety and efficacy profiles of enteral vitamin D in Black and White infants randomized to three different vitamin D doses soon after birth.

DESIGN

Ancillary study of a masked randomized clinical trial.

PARTICIPANTS/SETTING: Seventy-three infants born extremely preterm between 2012 and 2015 at a southern US academic neonatal unit (33' latitude) who had >90% compliance with the assigned intervention were included.

INTERVENTION

Infants were randomized to receive placebo (placebo group), 200 IU/day vitamin D (200 IU group), or 800 IU/day vitamin D (800 IU group) during the first 28 days after birth.

MAIN OUTCOME MEASURES

Safety outcomes included serum 25-hydroxy vitamin D (25[OH]D) and calcium concentrations. Efficacy outcomes included the predictive risk of bronchopulmonary dysplasia.

STATISTICAL ANALYSIS

Per-protocol analysis using unadjusted, repeated-measures mixed models.

RESULTS

Mean birth weight was 815 ± 199 g. Half were male and 56% were Black. Of 58 infants with 25(OH)D measurements at birth, 40 (69%) had vitamin D deficiency (<20 ng/mL). The mean difference in 25(OH)D in nanograms per milliliter between Postnatal Day 28 and Postnatal Day 1 was +9 in the placebo group, +23 in the 200 IU group, and +62 in the 800 IU group (P < 0.0001). The increase observed in 25(OH)D was more significant among Black infants. The predictive risk of severe bronchopulmonary dysplasia in the 200 IU and 800 IU groups was lower, but this difference did not reach statistical significance. No vitamin D or calcium toxicity was observed.

CONCLUSIONS

A vitamin D dose of 800 IU/day safely corrected vitamin D deficiency by Postnatal Day 14.

摘要

背景

尽管有大量证据表明，极早产儿（<28 周妊娠）的维生素 D 缺乏症非常普遍，但几项共识声明并不建议这些婴儿每天摄入>400IU 的维生素 D 剂量。安全性仍然是一个问题。

目的

本研究旨在确定黑人及白人婴儿在出生后不久随机接受三种不同维生素 D 剂量的肠内维生素 D 的安全性和疗效。

设计

一项盲法随机临床试验的辅助研究。

参与者/地点：2012 年至 2015 年，在美国南部一家学术新生儿单位（33 纬度）出生的 73 名极早产儿参与了该研究，他们的入组率>90%。这些婴儿出生后第 1 天至第 28 天期间被随机分配接受安慰剂（安慰剂组）、200IU/天的维生素 D（200IU 组）或 800IU/天的维生素 D（800IU 组）。

干预措施

婴儿接受肠内维生素 D 治疗。

主要观察指标

安全性指标包括血清 25-羟维生素 D（25[OH]D）和钙浓度。疗效指标包括预测支气管肺发育不良的风险。

统计分析

采用未调整的重复测量混合模型进行方案设定分析。

结果

平均出生体重为 815±199g，其中 50%为男性，56%为黑人。在 58 名出生时进行了 25(OH)D 检测的婴儿中，有 40 名（69%）存在维生素 D 缺乏症（<20ng/ml）。安慰剂组、200IU 组和 800IU 组在第 28 天和第 1 天的 25(OH)D 差值分别为+9ng/ml、+23ng/ml 和+62ng/ml（P<0.0001）。黑人婴儿的 25(OH)D 增加更显著。200IU 和 800IU 组严重支气管肺发育不良的预测风险较低，但差异无统计学意义。未观察到维生素 D 或钙毒性。